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Evaluation of a 'gist-based' information leaflet to be used in the NHS Bowel Cancer Screening Programme

Condition category

Cancer

Date applied

22/06/2012

Date assigned

22/06/2012

Last edited

05/05/2016

Prospective/Retrospective

Prospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsParticipation in the NHS Bowel Cancer Screening Programme is low, particularly in people from a lower socioeconomic status. The information materials provided to people can be difficult to understand for people with lower levels of literacy, and may therefore inadvertently discourage participation. This study aims to test a low literacy information booklet to be incorporated within the NHS Bowel Cancer Screening Programme.

Who can participate? Patients registered at four GP practices, aged 45-59

What does the study involve?Participants are randomly allocated to be sent either the standard information materials, or the standard materials along with a low literacy information booklet.

What are the possible benefits and risks of participating? Participants learn about the topic of bowel cancer and bowel cancer screening. There are no risks to taking part in the study.

Where is the study run from? CRUK & UCL Cancer Trials Centre (UK)

When is the study starting and how long is it expected to run for? July to September 2012

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12483

Study information

Scientific title

Evaluation of a 'gist-based' information leaflet to be used in the NHS Bowel Cancer Screening Programme: a randomised study

Acronym

Study hypothesis

Bowel cancer is the second most common cause of cancer death in the UK. Finding cancer early can save lives; therefore, in 2006, the NHS launched a Bowel Cancer Screening Programme (BCSP). In England, the BCSP offers screening to 60-69 year olds (up to 74 years in some areas). Screening involves completing a stool sample test kit, the faecal occult blood test (FOB) at home. Recent data suggests that only 54% of those offered the FOB test choose to do it. However, this figure varies from more than 60% in the most socially advantaged groups to less than 35% in the most disadvantaged groups. The current study is part of a larger research programme (the ASCEND Project) funded by the National Institute of Health Research (NIHR) that aims to reduce this difference in uptake rates between social groups. This study specifically aims to assess the influence of a gist-based leaflet developed by the research team, on future intentions to use the FOB test. Participants aged 45-59 (who have not yet taken part in the BCSP), will be recruited through GP practices. All participants will be sent the usual BCSP information leaflet 'Bowel Cancer Screening: The Facts', while the intervention group will also receive a gist-based leaflet. A questionnaire will ask about the participants views (e.g. intention to be screened, comprehension, attitudes, beliefs) on bowel cancer and bowel cancer screening. Answers will be compared between the two groups in order to assess the impact of the gist-based leaflet.

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

All participants will be sent the usual BCSP information leaflet 'Bowel Cancer Screening: The Facts', while the intervention group will also receive a gist-based leaflet.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Intention to be screened

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/07/2012

Overall trial end date

24/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Registered with a GP Practice2. Aged between 45-59, Male & Female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 840; UK Sample Size: 840

Participant exclusion criteria

1. Patients whom are unable or do not wish to provide informed consent2. Patients whom the GP advises should not be approached (e.g. recent diagnosis of cancer or other significant illness, terminally ill, learning disability, already receives regular colonoscopies)3. Patients who are not able to read English